what is USFDA & market complaint in pharmaceutical industry

what is USFDA & market complaint in pharmaceutical industry

 

Q.1 Why USFDA auait is important in pharmaceutical industry ?

1. Reg ulatory Compliance: USFDA audit compliance
ensures adherence to strict regulations for public health
and medication safety.

2. Market Access: Clearance of USFDA audit provides entry
to the profitable US pharmaceutical market.

3. Reputation Protection: Builds trust among stakeholders,
strengthening the company’s image.

4. Risk Mitigation: USFDA audit identifies and addresses:
compliance issues to prevent recalls and legal liab ‘

Q.2 What is frequency of USFDA audit in pharmaceutical
industry ?

Routine audits by the USFDA in pharmaceutical
manufacturing facilities vary but are generally
conducted every 2-3 years.

USFDA has the authority to conduct surprise audits,
also known as “for-cause inspections”. These audits
may be prompted by specific concerns, complaints,
or emerging issues regarding product safety, quality,
or regulatory compliance.

Q.3 What is form 482, form 483, form 484 and EIR ?

• Form 482 (Inspectional Observations): Notes potential violations found during an FDA inspection.
Form 483: Issued when significant violations are observed during an inspection.
Form 484: Documents official meetings or communication between the FDA and regulated entities.
EIR (Establishment Inspection Report): This report is generated by the FDA after an inspection
of a regulated establishment, such as a pharmaceutical or medical device manufacturing facility.

Q.4 In Which countries USDA has its offices?
The US Food and Drug Administration (USFDA) primarily operates within the United States. However,
it also has offices in select countries around the world, including:
1. China
2. India
3. Europe (specifically in Brussels, Belgium) 4. Latin America (Mexico City, Mexico) 5. Middle East (Riyadh, Saudi Arabia) 6. Southeast Asia (Singapore)

Q.5 What is typical content of 483 form ?

Issuing FDA field office name and address.
• Dates of inspections should be one day or as long as multiple weeks.
• FEI number – stands for the Firm Establishment Identifier & number created by corresponding district office.
Manufacturer’s contact info
• List of observations – typically, there’s somewhere between 5 and 10.
• Names and titles of the investigators – usually 1 or 2.

Q.6 Whether Form 483 and warning letter are same?
No, a Form 483 is an observation report, while a warning letter is a formal communication indicating more serious regulatory concerns.

Q.7 What are the key steps for USFDA approval for facility?
1. Facility Establishment: Build and establish the manufacturing facility.
2. Facility Registration: Register the facility with the FDA.
3. GMP Compliance: Ensure compliance with Good Manufacturing Practices (GMP) regulations.
4. Pre-Approval Inspection: Facility Undergo an inspection by the FDA before approval.
5. Approval Decision: Receive approval from the FDA to manufacture and distribute pharmaceutical products from the facility.

Q.8 Which sectors come under the purview of USFDA audit?
1. Pharmaceuticals
2. Medical Devices
3. Food and Beverages 4. Cosmetics
5. Tobacco Products
6. Biologics
7. Veterinary Products 8. Radiological Health

Q.9 When should a pharmaceutical company respond to a Form 483 issued by the USFDA ?
When a pharmaceutical company receives a Form 483 issued by the U.S. Food and Drug Administration (FDA), it is typically expected to respond promptly.
15 business days is often considered a reasonable timeframe for providing an initial response
The complexity of the observations and the required corrective actions may influence the actual timeline.

Q.10 What are some common areas or processes within a pharmaceutical facility that are typically scrutinized during a USFDA audit?
Area/Process
Quality Control and Assurance Good Manufacturing Practices (GMP) Documentation and Recordkeeping Facility and
Equipment Maintenance Personnel Training and Qualifications Cleaning and Sanitation Practices Raw Material Handling and Storage
Validation of Processes and Systems
Description
Systems for testing and monitoring product quality.
Compliance with regulations for manufacturing processes. Accuracy and completeness of records for traceability.
Maintenance of facilities and equipment to ensure integrity. Training programs to ensure staff competence and expertise.
Procedures for maintaining cleanliness and hygiene. Processes for receiving, storing, and handling raw materials.
Verification of processes and systems for consistency and ассыгасу,-

Q.11 What are the four types of USFDA inspections ?
1. Pre-approval inspections: Conducted to ensure compliance with regulations before product approval, focusing on facilities, processes, and controls.
2. Routine inspections: Periodic checks to monitor ongoing compliance with regulations and standards.
3. Follow-up inspections: Addressing previous non-compliance issues identified in previous inspections to ensure corrective actions have been taken.
4. For cause inspections: Prompted by specific concerns, complaints, or incidents, targeting areas of potential non-compliance or risks to public health.

Q.12 What is basic purpose of USFDA inspections ?
To determining firm’s compliance with applicable laws & regulations, such as drug,Food & Cosmetic Act and related Acts.

 

Q.14 Compliance with whicUSFDA guidelines is commonly checked during USFDA inspection ?
1. 21 CFR (Code of Federal Regulations): These regulations cover a wide range of topics related to pharmaceuticals,
including GMP (Part 210 and 211), IND requirements (Part 312), NDA requirements (Part 314), and many others.
2. ICH Guidelines (International Council for Harmonisation): These guidelines aim to standardize regulatory requirements globally.
Key ones include Quality (ICH Q8, Q9, Q10), Safety, Efficacy, and Multidisciplinary topics.
3. Good Manufacturing Practice (GMP) Guidelines: These outline minimum requirements for manufacturing, ensuring consistent quality.
Covered in 21 CFR Parts 210 and 211. 4. ICH Q9 – Quality Risk Management: Provides principles and tools for quality risk management,
applied throughout the product lifecycle.
5. ICH Q8 – Pharmaceutical Development: Guides a risk-based approach to product development, emphasizing understanding and control based on sound science

Q.15 What are some examples of God Manufacturing Practices (GMP) violations that could result in a Form 483 being issued by the USFDA?
1. Failure to establish and follow written procedures for production and process control.
2. Inadequate testing of incoming raw materials or finished products.
3. Lack of proper equipment maintenance and calibration.
4. Failure to maintain proper documentation of manufacturing processes and procedures.
5. Inadequate training of personnel involved in manufacturing processes. 6. Contamination of products due to improper handling or storage.
7. Failure to investigate and document deviations from established procedures.
8. Inaccurate or incomplete records related to production and quality control. 9. Failure to establish appropriate cleaning procedures for
equipment and facilitie 10.Inadequate systems for monitoring environmental conditions in manufacturing.

Q.16 What are the potential consequences for a pharmaceutical company if it fails to address the observations outlined in a Form 483 issued by the USFDA?
1. Warning Letter: The FDA may issue a formal warning if issues aren’t fixed. 2. Further Action like recalls or legal measures: If problems persist,
the FDA can take stronger actions like recalls or legal measures.
3. Product Recalls: Products may need to be recalled, hurting company
finances and reputation.
4. Suspended Market Approvals: Approval for affected products may be suspended or revoked.
5. Legal Issues: Fines, penalties, and lawsuits may follow non-compliance.
6. Reputation Damage: Trust and confidence in the company can suffer.
7. Delay in future Approvals: Delays or denials for new products could occur due to non-compliance

Q.17 What is Market complaint in pharmaceutical industry?

In the pharmaceutical industry, a “market complaint” refers to any feedback or report received from customers,
healthcare professionals, or regulatory authorities regarding issues with a pharmaceutical product’s quality,
safety, efficacy, packaging, labelling, or any other aspect related to its manufacture or use.

Q.18 What are the communication medium to receive market complaints in the pharmaceutical industry?
1. Customer Hotlines: Dedicated phone lines for direct complaints.
2. Email: Complaints sent via company email addresses.
3. Online Forms: Web-based submission forms on company websites.
4. Healthcare Professionals: Direct reports from medical staff.
5. Regulatory Authorities: Complaints forwarded by government agencies.
6. Social Media: Complaints voiced on platforms like Twitter or Facebook.
7. Sales Representatives: Feedback collected during sales visits.
8. Patient Support Programs: Programs allowing patients to report issues

Q. 19 What are the disadvantages / negative impact of Market complaint on pharma
industry?
1. Reputation Damage: Negative publicity harms trust.
2. Trigger of regulatory enquiry/inspection:Increased enquiry/ inspection and potential fines.
3. Legal Liabilities: Risk of lawsuits and legal actions.
4. Financial Losses: Costs of recalls and investigations.
5. Market Share Loss: Decreased consumer confidence.

Q.20 What are the different Categories of market complaint?
1. Quality: Issues with product consistency, potency, or stability.
2. Safety: Reports of adverse reactions or hazards.
3. Efficacy: Complaints about product effectiveness.
4. Packaging: Defects like leaks or labeling errors.
5. Dosage: Problems with forms, strengths, or instructions.
6. Supply Chain: Issues in distribution or storage.
7. Labeling: Errors on product information.
8. Customer Service: Feedback on company interactions.

Q.21 What should be investigation plan for market complaints in the pharmaceutical industry?
1. Define Objectives: Clearly state investigation goals.
2. Gather Information: Collect complaint details and relevant data.
3. Risk Assessment: Evaluate safety and quality risks.
4. Root Cause Analysis: Identify underlying reasons for the complaint.
5. Corrective Actions: Implement solutions to prevent recurrence.
6. Documentation: Maintain detailed records.
7. Communication: Share findings with stakeholders.
8. Follow-up: Monitor CAPA actions for effectiveness

Q.22 Which department is responsible for handling of market complaints in the pharmaceutical industry?
Quality Assurance Head coordinates all activities with marketing department till it get is closed.
In case of Critical Complaint: The batch shall be recalled as per plant specific SOP and shall follow procedure for recall,
handling and destruction.

Q.23 What are the different types based on the severity of market complaints?
A. Critical complaints: These are complaints that could result in serious health risks or death. Examples include:
1. Wrong product
2. Wrong strength
3. Wrong active ingredient
4. Adverse reaction leading to permanent damage/impairment or even death
5. Incorrect Manufacturing or Expiry dates, Label & Printed Foil, Product mix- ups, Batch mix-ups etc
6. Significant drop from reported assay value, abnormal impurity levels
B. Major complaints: These are complaints that could cause illness or mistreatment. Examples include:
1. Loss of potency
2. Significant discoloration
4. Product quality issues, including problems with appearance, taste, odor, texture, or packaging
5. Efficacy concerns, where consumers or healthcare professionals express doubts about the effectiveness of a pharmaceutical product
C. Minor complaints: These are complaints related to defect in product quality, packing defects which

Q.24 What Market complaint inveigation should compulsory include?
• Documentation of complaint details: Comprehensive record-keeping of complaint details.
Impact Evaluation: Assessment of complaint severity and potential safety impact.
• Root Cause Investigation: Identification of underlying issues leading to the complaint.